Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

June 20, 2022

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2026

Conditions
Malignant Melanoma
Interventions
COMBINATION_PRODUCT

Oral Decitabine/Cedazuridine (DEC-C) in Combination with Nivolumab

Activation of the RIG-I innate immune pathway and increased expression of tumor antigens and pro-immune genes during Nivolumab treatment may enhance the frequency and activity of anti-tumor immune cells (CD4+ and CD8+ T-cells, NK cells) and reduce the frequency and activity of immunosuppressive cells (MDSCs, Tregs) (1-4), increasing the overall effectiveness and success of Nivolumab treatment. This pilot clinical trial will demonstrate whether combinatorial immunotherapeutic approaches that target epigenetic immune repression and RIG-I activity can favorably alter the tumor immune cell microenvironment and benefit mucosal melanoma patients.

Trial Locations (1)

80045

University of Colorado Hospital, Aurora

All Listed Sponsors
collaborator

National Comprehensive Cancer Network

NETWORK

collaborator

Taiho Oncology, Inc.

INDUSTRY

lead

University of Colorado, Denver

OTHER